Evaluation of a Type I Collagen-Based Medical Device for Treating Thumb Base Osteoarthritis A Pilot Study on Performance and Safety of MD-Small Joints Collagen Medical Device

What this Trial Is About

Collagen is a key structural protein found in skin, cartilage, bone, and joints, known for its strength and flexibility. This research investigates a medical device called MD-Small Joints Collagen Medical Device, which uses type I collagen from swine, for treating symptomatic thumb base osteoarthritis. The study aims to evaluate the device's performance and safety in reducing pain and improving joint function in affected patients through a multicenter clinical investigation. Participants will receive a series of five injections of the collagen-based medical device. The first three injections are given both inside and around the thumb carpometacarpal joint, while the last two are administered only around the joint. Injections are performed weekly using sterile techniques with specific syringes and needles. The study measures the effects of this treatment at multiple time points: baseline (day 0), three weeks, six weeks, and sixteen weeks after starting treatment. Throughout the study, participants will undergo evaluations including pain assessments using the Visual Analogue Scale, functional tests such as the Disability of the Arm Shoulder and Hand score, and strength measurements like the Pinch Strength Test. Researchers will also monitor analgesic use through diaries and track any adverse events. These assessments will help determine the device's effectiveness in reducing pain and enhancing hand function over a 16-week period.

Evaluation of the Performance and Safety of a Type I Collagen-Based Medical Device (MD-Small Joints Collagen Medical Device) i the Treatment of RHIZOARTROSIS